MAUDE Adverse Event Report: COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Viral Infection (2248)

Event Date 05/03/2023

Event Type  Death  

Event Description

In hospital test kit use for covid-19 under emergency use authorization (eua): misdiagnosis and wrong treatment by invalid covid test resulting in death.Dr.Saeed qureshi 30 expert in medical diagnostic testing explains all covid tests are invalid at www.Bioanalyticx.Com there is no biological reference sample to which the tests are calibrated and validated.Must read contagion myth by dr.Tom cowan md for why "viruses" are similar to scurvy in human history- once thought to be highly contagious but is not.All flu/cold "symptoms" are not due to any virus and are not contagious.Www.Virustruth.Net/?ref=az."binovax?".See video lectures by virologist microbiologist dr.Stefan lanka and article "misconception called virus" explaining the invalid covid/virus test at website www.Virustruth.Net/?ref=az.Patients labeled "covid" have died due to misdiagnosis and wrong treatment.

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 17135791
• MDR Text Key: 317318487
• Report Number: MW5118404
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White